Adjustable vaginal splint for pelvic floor support

ABSTRACT

Vaginal splints and methods for their use for treating various pelvic floor conditions are provided. One embodiment of the vaginal splint includes a base portion having a configuration defined by first and second sides, a first connecting portion at a proximal side of the base portion and extending between a first end of each of the first and second sides, and a second connecting portion at a distal side of the base portion and extending between a second end of each of the first and second sides. The splint further includes an adjustable portion coupled to the base portion and positioned substantially adjacent to and distal of the second connecting portion of the base portion. The adjustable portion is removable by a user to thereby change the size of the splint.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/258,441, filed on Oct. 25, 2005.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to devices suitable for use in repairingvarious pelvic floor prolapse conditions. More particularly, the presentinvention relates to adjustable vaginal implants for such use andpurposes.

2. Background Discussion

Each year in the USA approximately 200,000 women undergo pelvic organprolapse surgery. Pelvic organ prolapse generally involves the descentof one or more of the uterus, the bladder or the rectum along the vaginatowards (or in extreme cases protruding beyond) the introitus. Women ofadvancing years, or those that have borne several children are morefrequent sufferers of pelvic organ prolapse. Traditional vaginal surgeryto address these conditions is associated with a high failure rate ofbetween 30-40%. Complex and elaborate abdominal, vaginal andlaparoscopic procedures such as abdominal sacral colpopexy, transvaginalsacrospinous ligament fixation and laparoscopic sacral colpopexy havebeen developed to reduce the risk of prolapse recurrence. Unfortunatelythese procedures require a high level of surgical expertise and are onlyavailable to a small number of specialist practitioners and therefore toa small number of patients. Details of various procedures currently inuse are described in Boyles S H., Weber A M, Meyn L. “Procedures forpelvic organ prolapse in the United States”, 1979-1997. American Journalof Obstetric Gynecology 2003, 188; 108-115.

Recently there has been a trend towards the use of reinforcing materialsto support a vaginal wall damaged by prolapse. Prosthetic materials suchas donor fascia lata, pig dermis and various types of synthetic meshhave been utilized with mixed success. These materials are generallypositioned under the vaginal wall or walls and sutured into position.

WO 2004/045457 discloses a different approach that utilizes a prostheticmaterial in repairing damaged vaginal walls, and subsequently inserts anintra-vaginal splint. The splint is placed into the vagina, and operatesto reduce the mobility of the vaginal walls. The repairs are typicallymade by dissecting either the posterior wall of the vagina or theanterior wall or the vagina or both. A graft of either syntheticmaterial, such as a polypropylene mesh or other fabric, or autologous oranalogous material is placed in the dissected area between the vaginalwall and the prolapsing organ. The vaginal incision is then closed bysuture or other tissue closure means, at which time the vaginal splintis inserted into the vagina and affixed to either wall. The splintstabilizes the vagina, keeps it elongated, and helps to hold the graftin place by preventing it from sliding or dislodging. Eventually thefascial tissue on each side of the graft will infiltrate into it therebyincorporating it into the body.

An aspect not addressed by WO 2004/045457, however, is the fact thatdifferent sized patients will require different sized splints. Simplyproviding the splints in numerous different sizes is not an economicalsolution. The present invention addresses this problem and providesimproved implants having adjustability features.

SUMMARY OF THE INVENTION

The present invention provides various embodiments of a vaginal splintand methods for treating pelvic floor conditions using such a splint.One embodiment is a vaginal splint sized and shaped for insertion withina vagina of a patient, the splint including a base portion having aconfiguration defined by first and second sides, a first connectingportion at a proximal side of the base portion and extending between afirst end of each of the first and second sides, and a second connectingportion at a distal side of the base portion and extending between asecond end of each of the first and second sides. It further includes anadjustable portion coupled to the base portion and positionedsubstantially adjacent to and distal of the second connecting portion ofthe base portion, wherein the adjustable portion is removable by a userto thereby change the size of the splint.

The base portion may have an overall substantially trapezoidalconfiguration, with the first and second connecting portions beingsubstantially parallel to one another, and the second connecting portionhaving a longer length than the first connecting portion. The adjustableportion may further include at least a first removable apical sectionhaving a connecting portion and first and second side portions at firstand second ends respectively of the connecting portion. The connectingportion of the first removable apical section is positionedsubstantially adjacent and parallel to the second connecting portion ofthe base portion. The first removable apical section may further beremovably coupled to the base portion by a joining portion capable ofbeing torn or cut by a user to thereby remove the first removable apicalsection from the base portion.

In yet another embodiment, the splint further includes a secondremovable apical portion having a connecting portion and first andsecond side portions at first and second ends respectively of saidconnecting portion. The second removable apical portion is removablycoupled to a distal side of the first removable apical portion and ispositioned substantially adjacent and parallel to the first removableapical portion. The second removable apical portion may further beremovably coupled to the first removable apical portion by a secondjoining portion capable of being torn or cut by a user to thereby removethe second removable apical portion from the first removable apicalportion. The splint may have a substantially trapezoidal configurationregardless of which, if any, of the first and second removable apicalportions are removed.

In another embodiment, the splint further includes an inflatable memberpositioned between the first and second sides and first and secondconnecting portions of the base portion. The inflatable member isinflatable by infusion of fluid therein between a deflated state whereinit does not extend outwardly beyond a top or bottom side of thecombination base portion and adjustable portion, and an inflated statedwherein it does extend outwardly beyond the top and/or bottom side ofthe combination base portion and adjustable portion. The inflatablemember may be a balloon made of a material selected from the groupconsisting of polyurethane, polyester, silicone and rubber.

In yet another embodiment, the distal side of the base portion has oneor more recesses therein, and wherein the first removable apical sectionhas one or more protruding elements extending from a proximal sidethereof. The one or more protruding elements are removably receivedwithin the one or more recesses in the base portion respectively tothereby removably secure the first removable apical portion to the baseportion.

This splint may further include a second removable apical portion havinga connecting portion and first and second side portions at first andsecond ends of said connecting portion respectively. The connectingportion of the second removable apical portion is positionedsubstantially adjacent to, distal of, and parallel to the connectingportion of the first removable apical portion. The second removableapical portion may further have one or more protruding elementsextending from a proximal side thereof. The one or more protrudingelements are removably received within one or more recesses in a distalside of the first removable apical portion to thereby removably securethe second removable apical portion to the first removable apicalportion.

The present invention also provides a method for treating a pelvic floorprolapse condition including providing a splint sized and shaped forinsertion within a patient's vagina. The splint includes a base portionhaving a configuration defined by first and second sides, a firstconnecting portion at a proximal side of the base portion and extendingbetween a first end of each of the first and second sides, and a secondconnecting portion at a distal side of the base portion and extendingbetween a second end of each of the first and second sides, and anadjustable portion coupled to the base portion. The adjustable portionis adjustable or removable by a user to thereby change the size of thesplint. The method further includes determining a size of a patientsvagina, and, based on said determined size, removing or adjusting saidadjustable portion if a different size is needed, and inserting thevaginal splint into the patient's vagina.

The adjustable portion may further include at least a first removableapical section having a connecting portion and first and second sideportions at first and second ends respectively of the connectingportion, and the removing or adjusting step may further include removingthe first removable apical section from the base portion. In yet anotherembodiment, the adjustable portion is coupled to the base portion by oneor more adjustment elements, and the removing or adjusting step furtherincludes moving the adjustable portion relative to the base portionalong the adjustment elements closer together or farther apart.

In yet another embodiment, the method further includes, following theinserting step, inflating an inflatable member positioned between thefirst and second sides and first and second connecting portions of thesplint to a state at which the inflatable member extends outwardlybeyond a top and/or bottom side of the splint.

The present invention further provides a vaginal splint sized and shapedfor insertion within a vagina of a patient, the splint including a baseportion having a connecting portion and first and second sides extendingin a distal direction from first and second ends of said connectingportion respectively to a free end, an adjustable portion having aconnecting portion and first and second sides extending in a proximaldirection from first and second ends of said connecting portionrespectively to a free end, the adjustable portion being positionedrelative to the base portion so that the first and second free ends ofthe base portion are substantially aligned with and opposed to the firstand second free ends of the adjustable portion, and means for adjustablycoupling together the base portion and adjustable portion so as to beadjustable relative to one another between first and second positionswherein the distance between the base portion and adjustable portion isdifferent between the first and second portions.

The means for coupling may further include at least first and secondadjustment elements each having first and second ends. The first endsare received within recesses in the free ends of the first and secondsides respectively of the base portion, and the second ends are receivedwithin recesses in the free ends of the first and second sidesrespectively of the adjustable portion. At least one of the adjustableportion and base portion is slidable relative to the first and secondadjustment elements.

In yet another embodiment, the base portion has an overall substantiallytrapezoidal configuration with the first and second connecting portionsbeing substantially parallel to one another, and the second connectingportion has a longer length than the first connecting portion.

In yet another embodiment, the splint further includes an inflatablemember positioned between the first and second sides and first andsecond connecting portion. The inflatable member is inflatable byinfusion of fluid therein between a deflated state wherein theinflatable member does not extend outwardly beyond a top or bottom sideof the combination base portion and adjustable portion, and an inflatedstate wherein it does extend outwardly beyond the top and/or bottom sideof the combination base portion and adjustable potion.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top view illustrating one embodiment of a splint accordingto the present invention;

FIG. 2 is a top view of the embodiment of FIG. 1 illustrating removal ofone of the apical portions;

FIG. 3 is a top view of the base portion of the embodiment of FIG. 1;

FIG. 4 is a front view of a removable apical portion of the embodimentof FIG. 1;

FIG. 5 is a top view illustrating another embodiment of a splintaccording to the present invention;

FIG. 6 is a top view of the embodiment of FIG. 5 illustrating removal ofthe apical portions;

FIG. 7 is a top view of yet another embodiment of a splint according tothe present invention;

FIGS. 8 and 9 illustrate the embodiment of FIG. 7 as further adjusted tovarious exemplary positions;

FIGS. 10, 10 a and 10 b are top, side and front views respectively of asplint having an inflatable member in a deflated state;

FIGS. 11, 11 a and 11 b are top, side and front views respectively ofthe embodiment of FIG. 10 with the inflatable member in an inflatedstate;

FIG. 12 is an exemplary mesh that can be used in conjunction with asplint for pelvic floor repair;

FIG. 13 illustrates placement of an exemplary mesh within the pelvis fortreating a prolapse condition;

FIG. 14 is a side view illustrating placement of a splint of the presentinvention within a patient; and

FIG. 15 illustrates the splint of FIG. 13 within a patient, with theinflatable member in an inflated state.

DETAILED DESCRIPTION OF THE INVENTION

Before explaining the present invention in detail, it should be notedthat the invention is not limited in its application or use to thedetails of construction and arrangement of parts illustrated in theaccompanying drawings and description. The invention as illustrated maybe implemented or incorporated in other embodiments, variations andmodifications, and may be practiced or carried out in various ways.

Referring now to FIGS. 1 to 3, according to one embodiment, theintra-vaginal splint 100 according to the present invention includes abase portion 102 and an adjustable portion 104. The base splint portionincludes first and second spaced apart sides 106, 108 each having first110, 112 and second 114, 116 ends. The sides are connected at theirrespective first ends by a first connecting portion 118, and at theirrespective second ends by a second connecting portion 120. The first andsecond connecting portions or members are preferably of differentlengths, but substantially parallel to one another. Further, the secondconnecting portion is preferably longer than the first connectingportion so that sides 106, 108 are not parallel with each other. In onepreferred form, the intra-vaginal base splint is substantiallytrapezoidal in overall shape. The first connecting portion 118 mayinclude an opening 180 therethrough for accepting an inflatable member,as will be described in more detail below.

The splint may be made out of medical grade silicone, polyurethane,polyvinylchloride (PVC), latex, or Santoprene™, although any othersuitable biocompatible materials may be used, such as natural rubbers,and blends or combinations of the previously noted materials. The splintmay be formed by liquid injection molding, thermoplastic molding, diecutting, machining, insert molding or any other manufacturing techniquewell known to those skilled in the art.

Preferably, the splint is resilient and at least partially bendableabout its longitudinal axis X-X (see FIG. 3). This feature facilitateseasy insertion of the splint into the vagina. The sides 106, 108 mayalso be reinforced to obtain a more rigid frame with rods, thickerwalls, higher durometer plastic, contouring or shaping of the side armsto resist bending, or by selective heat treating of portions and thelike.

In the present embodiment, the adjustable portion 104 includes one ormore removable apical sections 122 a, 122 b, a frontal view of which(apical section 122 a) is shown in FIG. 4. Each removable section 122 a,122 b includes first and second end portions 124 a, 126 a that extendslightly downwardly from the connecting portion 128 a. The connectingportion 128 a is substantially straight and parallel with connectingportion 120, and with the central portion 128 of the one or more otherremovable apical sections. These removable apical sections are connectedto one another and to the base splint portion 102 by one or more joiningportions or areas 109 of reduced wall thickness to facilitate trimming,tearing, or otherwise separating the apical section from the baseportion if necessary for sizing as described further below.

An alternate embodiment of an intra-vaginal splint is shown in FIGS. 4to 6. The intra-vaginal splint 100 is similar in overall configurationand appearance to the embodiment of FIGS. 1-3, but has a differentconfiguration for the adjustable portion or section 104, and for how theremovable apical sections 122 a, 122 b are coupled with the base portion102. As shown best in FIG. 6, each removable apical section 122 a, 122 bincludes one or more protruding elements 130 extending outwardly fromits proximal side 132. For the most proximal removable section 122 a,the one or more protruding elements 130 are designed to mate withcorresponding recesses 136 formed in the distal side 138 of theconnecting portion 120 of the base portion 102. The protruding elementsand corresponding recesses may be of any suitable form and configurationso as to achieve a snug interference fit that will secure the two piecestogether. Application of a predetermined force by a user, however,should be able to overcome the interference fit to separate the twopieces. In the illustrated embodiment, the one or more protrusions aresubstantially rigid, rod-like elements having a bulbous-like portion 140at their respective ends.

Further, all removable apical sections 122 a other than the most distalone 122 b have similar recesses 136 a formed in the distal side 134 thatare positioned and configured so as to accept the one or more protrudingelements of the subsequent removable section. As will be describedfurther below, these configurations and means for coupling the removableapical sections to the base portion provide a splint the size of whichcan be adjusted simply by removing one or more of the removable apicalsections.

Yet another embodiment of an adjustable vaginal splint 200 is shown inFIGS. 7-9. The splint 200 has a substantially trapezoidal overallconfiguration defined by a base portion 142 and a single adjustableapical section 144, and more particularly by first and second connectingportions 139, 141 and first and second side members 143, 145. The firstand second side members 143, 145 consist of first and second sides 146,148 that extend in a distal direction from first and second ends 151,153 of the first connecting portion 139 of the base portion, and firstand second sides 150, 152 that extend in a proximal direction from firstand second ends 155, 157 of the second connecting portion of theadjustable apical section. These respective sides mate with one anotherand are adjustably coupled with one another through adjustment elements154, 156. For each of the first and second adjustment elements 154, 156,first 166, 170 and second 168, 172 ends thereof are received withincorresponding cavities or recesses 158, 160; 162, 164 in the baseportion and adjustable apical section respectively. The adjustmentelements and corresponding recesses form an interference fit asdescribed above in connection with the second described embodiment. Inthe present embodiment, however, the adjustment elements further includetwo or more bulbous portions 174 at spaced apart intervals. Thesebulbous portions provide the tight interference fit, but withapplication of sufficient force by a user provide for adjustment of theadjustable section relative to the base portion to multiplepredetermined distances from one another.

The adjustment mechanism described above may also be used to provide foradjustment of the width W of the apical section 144. In this manner assingle apical section can be adjusted to various widths to provide evenbetter adjustability and fit.

Each of the embodiments described above may also include a thin membrane178 of the like extending across the top and/or bottom sides of thesplint so as to substantially cover the area between the first andsecond connection portions 139, 141 and the first and second sidemembers 143, 145. Each embodiment also preferably further includes anopening, hole or the like 180 that extends through the first connectingportion 118, through which an inflatable member, such as a balloon, canbe passed and positioned within the space between the first and secondconnecting portions and the first and second sides, and the top andbottom membranes if present. The inflatable member may or may not beremovably secured to the splint. Further details of such an inflatablemember are shown in FIGS. 10-10 b and 11-11 b.

Attached to the inflatable member 182 is an inflating tube 184 having alumen that communicates with the interior hollow of the inflatablemember and through which fluid can be infused. The inflatable member ispreferably positioned within the splint as described above in a deflatedstate as shown in FIGS. 10-10 b. The combination splint assembly isintroduced into the vagina and pressurized by fluid infusion (e.g. withsaline solution, air or the like) until it reaches a suitable inflatedstate such as that shown in FIGS. 11-11 b. With the addition of theinflatable member, the splint assembly can contact the lateral vaginalwalls and superior aspect of the vagina, as well as the upper and lowerwalls of the vagina. Thus, the splint assembly of the present inventioncan more completely fill the hollow of the vagina into which it isinserted and contact a greater surface area relative to the prior art.Additionally, since the inflatable member is preferably connected to thesplint loosely at only one end, pressure on the inflatable member is notdirectly translated to pressure on the splint. Consequently, the splintwill remain in its desired position and not be subjected to torqueforces produced by uneven contact between the balloon and vaginal walls.In this manner, the splint assembly has a hemostatic effect therebyimproving wound healing and strength, reduces movement and displacementof the mesh while it incorporates into the vaginal fascial tissues, andavoids the need to use supporting sutures in structures such as thesacrospinous ligament, the uterosacral ligaments or paravaginal tissues.Such sutures are often difficult to place and are associated withsignificant pain and patient morbidity.

The inflatable member preferably has a minimally extensible wall so thatit expands to a large diameter under low pressure so as not to interferewith tissue perfusion. This provides equal pressure between theinflatable member and tissue at all contact points. To the contrary, aninflatable member having a higher inflation pressure and greatlyextensible sidewalls is not easily conformable to a body cavity.Additionally, having a relatively thin wall provides good conformabilityof the inflatable member to the interior slope of the vagina withoutproducing pressure points on the vaginal wall. Thus, the inflatablemember conforms to the shape of the vagina instead of the vaginaconforming to the shape of the inflatable member. Suitable materials forthe inflatable member include polyurethane, polyester, polyethylene,silicones or other similar materials that can be formulated to havesimilar extension properties. Polyurethane, in particular, can be usedto form such an inflatable member having ideal mechanical andgeometrical properties, such as good tear, cutting and punctureresistance. The inflatable member may be manufactured by any suitablemethod, such as blow molding, dip molding, extrusion molding, orinjection molding. According to one preferred method, the inflatablemember is blow molded on pre-extruded tubing, which is axially andradially stretched in a blow molding process where the polymeric chainsare detangled and aligned in parallel.

A method for placing the adjustable splint assembly will now bedescribed with reference to FIGS. 13-15. For background reference, eachof these figures illustrates various aspects of the pelvic anatomy,including the bladder 195, vagina 196, cervix 199, and rectum 197. Anincision is first made in the vaginal epithelium that covers the vaginalwall, and the epithelium peeled and held away from the fascia. Lateraldissection is then carried out to and through the arcus tendinous fasciapelvic on both sides, and into the paravaginal spaces. The fascia ispreferably plicated once the epithelium has been mobilized off thefascia wall. A suitable implant, such as a mesh, is then positioned overthe defect of the exposed fascia. One exemplary mesh for anterior repairis shown in FIG. 12. This mesh is made of polypropylene, and ismanufactured and sold by Ethicon, Inc. of Somerville, N.J. The mesh 189has a central body portion 190 that is substantially oval in shape, andhas lateral extension arms 192. Once properly positioned over thedefect, the lateral extension arms 192 of the mesh may be placed intothe ipsilateral paravaginal space such that the lateral extension armscome into contact with the inner aspect of the pubic bone. The mesh maythen be attached to the fascia by sutures to hold it in place during theremainder of the procedure. Excess vaginal epithelium is then trimmedand the anterior vaginal wall is closed by sutures. The position of themesh within the pelvis is illustrated in FIG. 13.

At this point the surgeon determines the size of the vagina. Once thecorrect size for the intra-vaginal splint has been determined and theadjustable intra-vaginal splint assembly is adjusted to the correct sizeby trimming or adjusting the adjustable/removable apical section(s) asdescribed above, the splint is inserted into the vagina as shown in FIG.14. Preferably, the splint may be secured within the vagina by one ormore sutures or other attachment means to the epithelium of the vaginaeither in the anterior, posterior, or lateral walls. The inflatablemember is then inflated independently of the splint (as shown in FIG.15) to prevent the splint from dislodging from its desired position, orotherwise migrating during the healing period. For additional securityagainst accidental movement or dislodgement, one or two suture stitchesmay be used to attach the splint to the vaginal wall. As shown in FIG.11, the inflatable member is preferably shaped and sized so that it islarger in diameter at the distal end 210 than at the proximal end 212.This distal end is located in the apex of the vagina near the cervix,which is itself larger in diameter than the introital opening of thevagina and is more easily expandable. The inflatable member ispreferably retained in the vagina for a period of 1-2 days, but mayremain for a longer period if needed. The inflatable member can then bedeflated and removed from the splint and the body. The intra-vaginalsplint is preferably retained in the vagina for a period of four weeks,after which time the synthetic mesh has become incorporated into thetissue of each of the respective vaginal walls, and the splint can beremoved.

As described above, the inflatable member acts as a tamponade as doesthe common practice of packing the vagina with gauze. The presentdevice, however, provides several advantages in that it is more readilyconformable to the vaginal cavity to provide better coverage forhemostasis, it is smoother and thus less painful, and it is adjustable.Further, as the splint does not absorb blood or other fluids, excessiveor unusual bleeding can readily be detected.

It will be apparent from the foregoing that, while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1. A vaginal splint comprising: a base portion having a configurationdefined by first and second sides, a first connecting portion at aproximal side of the base portion and extending between a first end ofeach of the first and second sides, and a second connecting portion at adistal side of the base portion and extending between a second end ofeach of the first and second sides, and one or more recesses therein; anadjustable portion coupled to the base portion and having at least afirst removable apical section that further comprises a connectingportion, first and second side portions at first and second endsrespectively of the connecting portion, and one or more protrudingelements extending from a proximal side thereof, wherein the connectingportion of the first removable apical section is positionedsubstantially adjacent, distal and parallel to the second connectingportion of the base portion, wherein the vaginal splint is sized andshaped for insertion within a vagina of a patient so as to therebystabilize the vagina, and wherein the one or more protruding elementsare removably received within the one or more recesses in the baseportion respectively to thereby removably secure the first removableapical section to the base portion.
 2. The splint according to claim 1,further comprising a second removable apical section having a connectingportion and first and second side portions at first and second ends ofsaid connecting portion respectively, wherein the connecting portion ofthe second removable apical section is positioned substantiallyadjacent, distal, and parallel to the connecting portion of the firstremovable apical section.
 3. The splint according to claim 2, whereinthe second removable apical section has one or more protruding elementsextending from a proximal side thereof, and wherein said one or moreprotruding elements are removably received within one or more recessesin a distal side of the first removable apical section to therebyremovably secure the second removable apical section to the firstremovable apical section.
 4. The splint according to claim 2, whereinthe splint has a substantially trapezoidal configuration regardless ofwhich, if any, of the first and second removable apical sections areremoved.
 5. The splint according to claim 1, further comprising aninflatable member positioned between the first and second sides andfirst and second connecting portions, the inflatable member beinginflatable by infusion of fluid therein between a deflated state whereinit does not extend outwardly beyond a top or bottom side of thecombination base portion and adjustable portion, and an inflated statedwherein it does extend outwardly beyond the top and/or bottom side ofthe combination base portion and adjustable portion.
 6. The splintaccording to claim 5, wherein the inflatable member is a ballooncomprised of a material selected from the group consisting ofpolyurethane, polyester, silicone and rubber.
 7. A method for treating apelvic floor prolapse condition comprising: providing a splint sized andshaped for insertion within a patient's vagina, the splint including abase portion having a configuration defined by first and second sides, afirst connecting portion at a proximal side of the base portion andextending between a first end of each of the first and second sides, anda second connecting portion at a distal side of the base portion andextending between a second end of each of the first and second sides,and an adjustable portion coupled to the base portion, wherein theadjustable portion is coupled to the base portion by one or moreadjustment elements and is adjustable or removable by a user to therebychange the size of the splint, and further comprises at least a firstremovable apical section having a connecting portion and first andsecond side portions at first and second ends respectively of theconnecting portion; determining a size of a patients vagina; based onsaid determined size, removing or adjusting said adjustable portion if adifferent size is needed by moving the adjustable portion relative tothe base portion along the adjustment elements; and inserting thevaginal splint into the patient's vagina.
 8. The method according toclaim 7, further comprising, following the inserting step, inflating aninflatable member positioned between the first and second sides andfirst and second connecting portions of the splint to a state at whichthe inflatable member extends outwardly beyond a top and/or bottom sideof the splint.
 9. A vaginal splint sized and shaped for insertion withina vagina of a patient, the splint comprising: a base portion having aconnecting portion and first and second sides extending in a distaldirection from first and second ends of said connecting portionrespectively to a free end; an adjustable portion having a connectingportion and first and second sides extending in a proximal directionfrom first and second ends of said connecting portion respectively to afree end, the adjustable portion being positioned relative to the baseportion so that the first and second free ends of the base portion aresubstantially aligned with and opposed to the first and second free endsof the adjustable portion, and means for adjustably coupling togetherthe base portion and adjustable portion so as to be adjustable relativeto one another between first and second positions wherein the distancebetween the base portion and adjustable portion is different between thefirst and second portions.
 10. The splint according to claim 9, whereinthe means for coupling is at least first and second adjustment elementseach having first and second ends, said first ends being received withinrecesses in the free ends of the first and second sides respectively ofthe base portion, and the second ends being received within recesses inthe free ends of the first and second sides respectively of theadjustable portion, wherein at least one of the adjustable portion andbase portion is slidable relative to the first and second adjustmentelements.
 11. The splint according to claim 10, wherein the base portionhas an overall substantially trapezoidal configuration with the firstand second connecting portions being substantially parallel to oneanother, and the second connecting portion has a longer length than thefirst connecting portion.
 12. The splint according to claim 10, furthercomprising an inflatable member positioned between the first and secondsides and first and second connecting portion, the inflatable memberbeing inflatable by infusion of fluid therein between a deflated statewherein the inflatable member does not extend outwardly beyond a top orbottom side of the combination base portion and adjustable portion, andan inflated state wherein it does extend outwardly beyond the top and/orbottom side of the combination base portion and adjustable potion.